[Special Stock] PCL Designated as Public Health Emergency Response Product for COVID-19 Diagnostic Kits... Priority for National Procurement

Approval Expected for Saliva-Based COVID-19 Self-Test... Omicron Self-Diagnosis Useful

[Asia Economy Reporter Hyungsoo Park] PCL is showing strong performance. The recent designation of two types of COVID-19 rapid antigen test kits as ‘Public Health Emergency Medical Products’ by the Ministry of Food and Drug Safety appears to have influenced the stock price.

As of 9:57 AM on the 10th, PCL is trading at 44,000 KRW, up 14.43% from the previous day.

Both diagnostic kits designated as Public Health Emergency Medical Products were approved using specimens collected from the back of the nose (nasopharyngeal). The 'Enforcement Rules of the Special Act on the Promotion of Development and Emergency Supply of Medical Products for Public Health Emergencies' announced by the Ministry of Food and Drug Safety systematizes the urgent supply of necessary medical products during public health emergencies. Public Health Emergency Medical Products are given priority in national procurement. Companies must report production volume, sales volume, prices, and other details to the government.

The professional-use PCL COVID19 Ag Gold takes about 10 minutes to confirm results. It can detect various virus variants. PCL conducted comparative experiments on this product using nasal specimen collection methods through the German Red Cross Blood Service. The results confirmed that its sensitivity is about 10 times higher compared to domestic and international products.

A PCL official stated, "The designation of two products as Public Health Emergency Medical Products by the Ministry of Food and Drug Safety has proven their excellent competitiveness," adding, "The strength lies in helping to accurately and quickly determine positive cases."

Among the PCL COVID19 Ag Gold product line, the self-diagnostic product using saliva as a specimen is currently awaiting approval from the Ministry of Food and Drug Safety. The results are expected by the 16th, marking six months since the application for product approval was submitted.

PCL conducted usability evaluations for the self-diagnostic PCL COVID19 Ag Gold on individuals aged 2 to 80 at Gangnam Severance Hospital. Clinical trials were also conducted at the Royal Hospital COVID Testing Center in Morocco. Through clinical sensitivity and specificity verification of saliva specimens, the effectiveness of self-testing was demonstrated. PCL expects that the saliva-based method will be more useful for rapid antigen self-diagnosis of the COVID-19 Omicron variant.

The New York Times introduced research by Professor Donald Milton of the University of Maryland last month, which showed that from three days before symptom onset due to Omicron COVID-19 to five days after, the amount of virus detected in saliva is about three times higher than in the nasal cavity (nasal swab).